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Neo-MILK: Structural promotion and establishment donor human milk banks in German neonatal intensive care units (interventional study)

Neo-MILK: Structural promotion and establishment donor human milk banks in German neonatal intensive care units (interventional study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025058
Enrollment
960
Registered
2021-05-06
Start date
2022-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.01 P07.02 P07.10 P07.11 P07.00

Interventions

Group 1: In the control group, the preterm infants and their mothers receive the standard care that corresponds to the standard of the respective hospital. It cannot be ruled out that the control grou

Sponsors

Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu Köln
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Level of hospital: Hospitals can participate in the study if they have neonatal intensive care units of level I or II. Level of preterm infants: At the preterm level, preterm infants with a birth weight below 1,500 grams (ICD-10-GM: P07.00, P07.01, P07.02, P07.10, P07.11) born in one of the participating hospitals and cared for in the NICU during the recruitment period are included anonymously in the data collection. The preterm infants will be cared for according to the group status of the respective hospital. Level of mothers: At the maternal level, those mothers are included who gave birth to a preterm infant weighing less than 1,500 grams in one of the hospitals participating in the study during the study period.

Exclusion criteria

Exclusion criteria: Level of hospital: Hospitals that are already participating in a comparable project are excluded. Level of preterm infants: Preterm infants with a birth weight of more than 1,500 grams, preterm infants with lethal malformations and infants transferred to the NICU are excluded. Level of mothers: Mothers of preterm infants weighing more than 1,500 grams, preterm infants with lethal malformations, and mothers of infants transferred to the NICU are excluded.

Design outcomes

Primary

MeasureTime frame
The primary endpoint was the nutritional status of preterm infants (birth weight less than 1,500 grams) on breast milk at transfer or discharge from a Level I or Level II NICU. Breast milk is defined as that given by the birth mother. Donor breast milk, on the other hand, is given by a woman who is not the birth mother.

Secondary

MeasureTime frame
Impact of the interventon on 1) complications in prematurely born infants, type and quantity of feeding and the period of hospitalisation as well as on 2) the willingness to breastfeed/lactate and the behaviour towards breastfeeding and donation of breast milk among mothers

Countries

Germany

Contacts

Public ContactJuliane Köberlein-Neu

Bergisches Kompetenzzentrum für Versorgungsforschung und Gesundheitsökonomik, Bergische Universität Wuppertal

koeberlein@wiwi.uni-wuppertal.de0202/439-1381

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 8, 2026